Abstract
Introduction and Aims: In the original randomised USFDA multi-centre clinical trial, the radiographic results showed superior surgical technique for ROBODOC, but at the expense of increased surgical time (258 min. vs. 134 min.) and blood loss (1189cc vs. 644cc). Although this did not result in any increase in complications, improvements in the method of registration (DigiMatchTM) and faster cutting times have resulted in a more efficient procedure. This study represents a preliminary report of the blood loss and surgical time encountered in a new randomised controlled study of the DigiMatchTM version of ROBODOC.
Method: This is an uneven randomised controlled study comparing primary THR using the DigiMatchTM ROBODOC Surgical Assistant (Integrated Surgical Systems, Inc.) with the standard conventional technique. To date there are 80 consecutive patients (three bilateral) with 83 hips (65 Robodoc, 18 control). Inclusion and exclusion criteria, similar to those used in the initial USFDA multi-centre trial, were used in this study. The blood loss (as estimated by the anesthesiologist) and the surgical time (from incision to skin closure) were recorded and analysed using ANOVA.
Results: Average age (59.15 vs. 60.17 years) and weight (190.92 vs. 188.50 lbs.) were not significantly different (p> 0.65). The avgerage blood loss was also not significantly different (471.54cc for Robodoc vs. 405.56 for control, p=0.256) with a 95% confidence interval of −174.4 to +42.4cc. Surgical time was different at 121.92 min. for Robodoc and 85min. for control (p< 0.00). There was no difference in the need for transfusion. There were no device-related adverse events.
Conclusion: The results of this preliminary report of the DigiMatchTM Robodoc Surgical Assistant, coupled with the prior finding of improved radiographic results, seem to validate the initial concept and indicate the potential clinical utility of the device. We anxiously await the combined results of the three centres currently participating in the study.
These abstracts were prepared by Editorial Secretary, George Sikorski. Correspondence should be addressed to Australian Orthopaedic Association, Ground Floor, The William Bland Centre, 229 Macquarie Street, Sydney, NSW 2000, Australia.
At least one of the authors is receiving or has received material benefits or support from a commercial source.
